GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Address:4560 HORTON ST,Emeryville,CA,94608,US

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Device Description : The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system fo The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system fo The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system fo The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system fo The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system fo The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system fo The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : A collection of reagents and other associated materials intended to be used to g A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : A collection of reagents and other associated materials intended to be used to o A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : A collection of reagents and other associated materials intended to be used to o A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Device Description : A collection of reagents and other associated materials intended to be used to o A collection of reagents and other associated materials intended to be used to optimize an assay performed using a nucleic acid technique (NAT) on a clinical specimen.

Device Class :

Duns Number: 056570085

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1